Regulatory Updates
Listing of Colour Additives Exempt from Certification; Food, Drug, and Cosmetic Labeling; Cochineal Extract and Carmine Declaration, Final Rule
Distribution date: 12 January 2009 | Final date for Comment: 04 February 2009
On 5 January 2009, FDA issued a final rule to require the declaration by name of the colour additives carmine and cochineal extract on all foods and cosmetics. The final rule published in the Federal Register at 74 FR 207 (available in English). Text can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-31253.htm. For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the Docket No. FDA-1998-P-0032 (formerly Docket Number 1998P-0724) into the "Search" box and follow the prompts. This action is subsequent to a proposed rule published in the Federal Register on 30 January 2006. This notice can be found at: Federal Register: 30 January 2006 (Volume 71, Number 19) Notices Page 4839-4851; http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1104.htm.
Products Covered:
Regulation Type: Addendum to Regular Notification
AGENCY: Food and Drug Administration (FDA), HHS ; ; ACTION: Final rule ; ; TITLE: Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration ; ; SUMMARY: The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. ; ; COMMENT DEADLINE: 4 February 2009 ; ; EFFECTIVE DATE: 9 January 2011 ; ; FOR FURTHER INFORMATION CONTACT: ; Mical Honigfort ; Center for Food Safety and Applied Nutrition (HFS-265) ; Food and Drug Administration ; 5100 Paint Branch Parkway ; College Park, MD 20740 USA ; T: 301-436-1278 ; Email: mical.honigfort@fda.hhs.gov ; ; Full text is at: ; http://edocket.access.gpo.gov/2009/E8-31253.htm ; http://edocket.access.gpo.gov/2009/pdf/E8-31253.pdf ;
Distribution date: 12 January 2009
Products Covered: Colour Additives in Food, Drugs, and Cosmetics (HS Chapter 3003 and 3304 ) (ICS 11,67, and 71)
Regulation Type: Addendum to Regular Notification
"Commission Decision 2008/921/EC of 9 December 2008 amending Decision 2008/798/EC". http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:331:0019:0020:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:331:0019:0020:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:331:0019:0020:ES:PDF and/or http://members.wto.org/crnattachments/2008/sps/EEC/08_4081_00_e.pdf http://members.wto.org/crnattachments/2008/sps/EEC/08_4081_00_f.pdf http://members.wto.org/crnattachments/2008/sps/EEC/08_4081_00_s.pdf
Distribution date: 24 December 2008
The prohibition of import is extended to products containing soya and soya products intended for use by infants and young children originating in or consigned from China and the 100 % testing at import is extended to feed and food containing soya and soya products originating in or consigned from China and the additive ammonium bicarbonate imported from China.
Products Covered: Products containing soya and soya products intended for use by infants and young children, feed and food containing soya and soya products and ammonium bicarbonate
Regulation Type: Emergency notifications (SPS)
Notice: Registration Review; Citric Acid, and Salts Docket Opened for Review and Comment
Distribution date: 23 December 2008 | Final date for Comment: 17 March 2009
EPA has established registration review dockets for the Citric Acid, and Salts (EPA-HQ-OPP-2008-08). With this document, EPA is opening the public comment period for these registration reviews. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Registration review dockets contain information that will assist the public in understanding the types of information and issues that the Agency may consider during the course of registration reviews. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment. Please refer to the docket number if submitting information or comments.
Products Covered: Various
Regulation Type: Regular notification
Draft Import Health Standard: Fertilisers and Growing Media of Plant Origins
Distribution date: 09 December 2008 | Final date for Comment: 07 February 2009
New Zealand has distributed a draft import health standard for the importation of fertilisers and growing media products of plant origins which is now available for consultation.
Products Covered: Miscellaneous products made up of plant material that are used as fertilisers and growing media
Regulation Type: Regular notification
Notification of the Department of Industrial Works Regarding Timeframe for Removal of Polychlorinated Biphenyl (PCBs)
Distribution date: 08 December 2008 | Final date for Comment: 06 February 2009
The Department of Industrial Works established timeframe for phase-out and elimination of PCBs and PCBs containing equipment by 2012.
Products Covered: Hazardous substance (HS: 3824, ICS: 13.030.30)
Regulation Type: Regular notification
Resolución Nº 200/08 "Por la cual se amplia el Artículo N° 2 de la Resolución N° 139/07 en lo referente a pasos de frontera únicos para el ingreso terrestre de plaguicidas de uso agrícola" (Resolution No. 200/08 "Extending Article 2 of Resolution No. 139/07 in respect of single border-crossing points for the entry into Paraguay by land of agricultural pesticides").
Distribution date: 03 December 2008
The notified Resolution establishes the Puerto José Falcón border crossing as an land entry into Paraguay for agricultural pesticides.
Products Covered: Agrochemicals falling under MERCOSUR Common Nomenclature (NCM) tariff heading 3808
Regulation Type: Regular notification
Order of the Minister of Agriculture of the Republic of Armenia No. 209-N of 24 October 2008 "On the Approval of Changes in the Order of the Minister of Agriculture of the Republic of Armenia No. 198-N adopted on 18 November 2003"
Distribution date: 03 December 2008
It is stipulated by this Order to add protection measures for newly registered plants in the list of plant protection chemical and biological measures, permitted for use in the territory of the Republic of Armenia.
Products Covered: Plant protection measures
Regulation Type: Regular notification
Import Directive for Highly Processed Products
Distribution date: 28 November 2008 | Final date for Comment: 27 January 2009
The changes to the Highly Processed Products Directive were put in place to reflect Canadian Food Inspection Agency and Health Canada legislative and policy requirements for removal of specified risk material (SRM) from all cattle at slaughter. SRM refers to any of the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and the distal ileum of cattle of all ages. All removed SRM are to be diverted away from the products for human consumption and animal food supply. The requirement to remove all SRM from cattle does not apply to products originating from a country that is designated as having negligible risk of BSE. The changes are also made in light of the recognition of the Bovine Spongiform Encephalopathy (BSE) status of OIE members, where a number of countries have recently been reclassified from negligible to controlled risk for BSE in accordance with the updated Terrestrial Animal Health Code (27 May 2008) of the OIE.
Products Covered: Highly processed products of animal origin (e.g. gelatine) (ICS Codes 65.020, 67.040)
Regulation Type: Regular notification
Proyecto de Decreto del Ministerio de la Protección Social "Por el cual se reglamenta parcialmente el Título V de la Ley 09 de 1979, en lo referente a los establecimientos de alcohol y bebidas alcohólicas, elaboración, hidratación, envase, distribución, venta, exportación e importación de estos productos y se dictan otras disposiciones" (Draft Decree of the Ministry of Social Welfare "establishing partial regulations under Title V of Law No. 09 of 1979 in respect of establishments which produce, hydrate, package, distribute, sell, export and import alcohol and alcoholic beverages, and issuing other provisions") (available in Spanish, 89 pages).
Distribution date: 25 November 2008 | Final date for Comment: 20 February 2009
Purpose and scope; Definitions; Basic hygiene requirements for the manufacture of alcohol and alcoholic beverages; Buildings and installations; Equipment and utensils; Product handlers; Hygiene requirements during the manufacturing process; Sanitation; Storage, distribution, transportation and marketing; Quality assurance and control; Technical specifications; Processes; Physico-chemical requirements for pure and extra-neutral ethyl alcohol, neutral rectified alcohol, sugar cane rum ("aguardiente de caña", "caña", "cachaza" and "branquiña"), anisette and aniseed liqueur ("anís" and "anisado"), aperitifs, brandy, beer, gin, rum, "sabajón" (Colombian egg liqueur), wine, vodka and whisky; Packaging, labelling and advertising; Sanitary registration; Imports; Exports; Inspection, monitoring and control; Sanitary safety measures and preventive sanitary measures; Penalty procedure; List of additives (Annex 1).
Products Covered: Alcohol, alcoholic beverages
Regulation Type: Regular notification
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